RT Journal Article SR Electronic T1 Pharmacokinetic bioequivalence of inhaled CHF 1535 50/6 vs. the free combination of beclomethasone and formoterol in asthmatic children JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP p826 VO 38 IS Suppl 55 A1 Bo L.K. Chawes A1 Annalisa Piccinno A1 Eskil Kreiner-Møller A1 Nanna L. Skytt A1 Nasim Samandari A1 Francesco Sergio A1 Giorgia Ciurlia A1 Daniela Acerbi A1 Hans Bisgaard YR 2011 UL http://erj.ersjournals.com/content/38/Suppl_55/p826.abstract AB Rationale: To develop a new fixed formulation of Beclomethasone dipropionate (BDP) 50μg and Formoterol fumarate 6μg (CHF 1535 50/6) delivered via a pMDI for treatment of children with severe asthma.Objective: To investigate pharmacokinetic of B17MP (active BDP metabolite) and Formoterol in children with asthma after inhalation of CHF 1535 50/6 vs. the licensed free combination of BDP and Formoterol dispensed with AeroChamber Plus™.Methods: 22 children (5-11yrs) with mild asthma were included in this open-label, randomised, 2-way cross-over study of inhaled BDP 200μg and Formoterol 24μg. Eight-hour pharmacokinetic profiles (Cmax and AUC0-t) for B17MP and Formoterol after single inhalation were primary endpoints evaluated by analysis of variance and 90% bioequivalence limits.Secondary endpoints were pharmacodynamics: serum potassium, heart rate, and cortisol excretion.Results: B17MP and Formoterol pharmacokinetic parameters showed comparable values and the upper limit of the 90% CI was well within the bioequivalence limit. The pharmacodynamic parameters also showed similar values after both treatments.Conclusion: After CHF 1535 50/6 administration, the BDP and Formoterol systemic exposure was similar to the systemic exposure of BDP and Formoterol administered as free combination supporting a comparable safety profile in children aged 5-11yrs.